Neuropathic pain is a severe pathological condition of the nervous system. Neuropathic pain results from damage or abnormal function of the central or peripheral nervous system. Neuropathic pain is caused by lesion or inflammation of the nervous system and is relatively common with an incidence estimated at 0.6% to 1.5% in the Indian population. Neuropathic pain is probably multifactorial pathophysiological process.
Patients with neuropathic pain frequently report sensory abnormalities including burning sensations, as unpleasant abnormal sensation (dysesthesia), an increased response to painful stimuli (hyperalgesia), and pain in response to a stimulus that does not normally provoke pain (allodynia).
Hyperalgesia is increased pain sensitivity or a state of increased intensity of pain sensation induced by either noxious or ordinarily non-noxious stimulation of peripheral tissue. Allodynia is pain in response to a non-nociceptive stimulus. Hyperalgesia and allodynia are classified according to the type of stimulus which elicits the sensation of pain. Thermal (heat or cold) stimuli or mechanical brush, pinch, or pressure stimuli are most often used. In addition, moving (dynamic) or static mechanical touch stimuli are being used. Thereby, mechanical and thermal (heat or cold) hyperalgesia and mechanical dynamic allodynia can be differentiated.
Peripheral nerves carry information to and from the brain. They also carry signals to and from the spinal cord to the rest of the body. Peripheral neuropathy means these nerves don't work properly. Peripheral neuropathy may be due to damage to a single nerve or a nerve group. Because of this, pain sensitivity for anything that is too hot or cold may get lost. Patients with peripheral neuropathy may have tingling, numbness, unusual sensations, weakness, or burning pain in the affected area. The symptoms are symmetrical and involve both hands and feet.
Peripheral neuropathy is disorder of nerve(s) apart from the brain and spinal cord. Peripheral neuropathy can involve different nerve types, including motor, sensory, and autonomic nerves. Peripheral neuropathy can also be categorized by the size of the nerve fibers involved, large or small.
Mononeuropathy is a type of damage to nerves outside the brain and spinal cord (peripheral neuropathy). Mononeuropathy is most often caused by injury, although body-wide (systemic) disorders may cause isolated nerve damage. Long-term pressure on a nerve due to swelling or injury can result in Mononeuropathy. The covering of the nerve (myelin sheath) or part of the nerve cell (the axon) may be damaged. This damage slows or prevents signals from traveling through the damaged nerves. Mononeuropathy may involve any part of the body.
Some of the common forms of Mononeuropathy include:                Axillary nerve dysfunction (Axillary nerve palsy)        Carpal tunnel syndrome (median nerve dysfunction)        Femoral nerve dysfunction        Radial nerve dysfunction        Sciatic nerve dysfunction (sciatica)        Ulnar nerve dysfunction (cubital tunnel syndrome)Existing Therapies for Neuropathic Pain:        
Transcutaneous electrical nerve stimulation (TENS) may help to relieve symptoms. In this therapy, adhesive electrodes are placed on the skin and a gentle electric current is delivered through the electrodes at varying frequencies. TENS should be applied for 30 minutes daily for about a month. TENS is an inexpensive, noninvasive, self-administered technique that delivers pulsed electrical currents across the intact surface of the skin to relieve pain. The technique has some drawbacks such as use of TENS is likely to be less effective on areas of numb skin/decreased sensation due to nerve damage. It may also cause skin irritation due to the inability to feel currents until they are too high. There is an unknown level of risk when placing electrodes over an infection (possible spreading due to muscle contractions), but cross contamination with the electrodes themselves is of greater concern. TENS should also be used with caution in people with epilepsy or pregnant women.
Acupuncture involves the insertion of thin needles into various points on your body. Acupuncture may reduce symptoms in people with peripheral neuropathy. The therapy has some drawbacks that the patient may suffer from various infectious diseases, if the needles are re-used or not sterile. The effectiveness of acupuncture varies from person to person. Few complications have been reported due to the use of needles. If the needles are not inserted properly, it may lead to organ rupture or infection.
Although lot of medications and therapies are available to deal with neuropathic pain or neuropathy, they are with either side effects or are expensive over a long period of time. Hence there is a need to come up with such a novel composition that would not only deal with the pain but also would be cost effective.
Existing Medications:
Many types of medications have been reported to relieve the pain of peripheral neuropathy, including: Pain relievers, non-steroidal anti-inflammatory drugs, Medications containing opioids, such as tramadol (Ultram ER) or oxycodone (Roxicodone) etc. These drugs lead to dependence and addiction, so these drugs are generally prescribed only when other treatments fail. Capsaicin, A cream containing this naturally occurring substance found in hot peppers has shown modest improvements in peripheral neuropathy symptoms. Lidocaine patch may help reduce pain from peripheral neuropathy with side effects such as redness, swelling, irritation, itchiness.
Certain tricyclic antidepressant medications, such as amitriptyline, doxepin and nortriptyline (Aventyl, Pamelor), have been found to help relieve pain by interfering with chemical processes in brain and spinal cord that cause to feel pain. But they have shown many side effects such as dry mouth, nausea, drowsiness, dizziness, decreased appetite and constipation. Pregabalin can be used as an initial treatment for neuropathic pain. The two most common side effects of pregabalin are: dizziness, tiredness.
Alpha-lipoic acid is used as a treatment for peripheral neuropathy in Europe for years. This antioxidant may help reduce the symptoms of peripheral neuropathy. Side effects may include stomach upset, skin rash and it may affect blood sugar levels also.
Fenugreek (Trigonella foenum-graecum) is rich in phytochemicals and has traditionally been used as a food, forage and medicinal plant. Fenugreek has a long history of medical uses in Ayurvedic and Chinese medicine, and has been used for numerous indications, including labor induction, aiding digestion, and as a general tonic to improve metabolism and health.
Fenugreek is rich in chemical constituents. Fenugreek seed contains carbohydrates, mainly mucilaginous fiber (galactomannans); proteins high in lysine and tryptophan; fixed oils (lipids); pyridine-type alkaloids, mainly trigonelline, choline, gentianine, and carpaine; the flavonoids apigenin, luteolin, orientin, quercetin, vitexin, and isovitexin; free amino acids, such as 4-hydroxyisoleucine, arginine, histidine, and lysine; calcium and iron; saponins, glycosides yielding steroidal sapogenins on hydrolysis (diosgenin, yamogenin, tigogenin, neotigogenin); cholesterol and sitosterol; vitamins A, B1, C, and nicotinic acid; volatile oils (n-alkanes and sesquiterpenes) and sugars such as raffinose, stachyose, sucrose, fructose, mannose, verbascose and xylose.
The seeds also contain the saponin fenugrin B, coumarin compounds. The seed is also responsible for fixed oil. Several C-glycoside flavones have been identified in the seeds of fenugreek. These include vitexin, vitexin glycoside, and an arabinoside of orientin (iso-orientin), minor steroidal sapogenins (fenugreekine, smilagenin, sarsasapogenin, yuccagenin), and up to 50% of mucilaginous fiber.
These different chemical constituents have shown diverse therapeutic effects. The component called fenugreekine; a steroidal sapogenin peptide ester has hypoglycemic properties and has shown improved pancreatic function. It helps to delay gastric emptying, slow carbohydrate absorption, and inhibit glucose transport in humans. Trigonelline is suggested to exert hypoglycemic effects in healthy patients without diabetes. The steroidal saponins (diosgenin, yamogenin, tigogenin and neotigogenin) are thought to inhibit cholesterol absorption and synthesis and hence its potential role in arteriosclerosis. It is also used topically to treat inflammation, and to promote postpartum lactation in animals. At present diosgenin, a steroid sapogenin is used in the manufacture of birth control pills. Plant phenolics have potential health benefits mainly due to their antioxidant properties such as reactive oxygen species (ROS) scavenging and inhibition, electrophile scavenging and metal chelation. They have also been reported to exhibit pharmacological properties such as antitumor, antiviral, antimicrobial, anti-inflammatory, hypotensive and antioxidant activity.
Eleutherococcus senticosus which is formerly labeled as Siberian Ginseng, is often referred to also as Ciwujia E., thorny ginseng or Eleuthero. This botanical source is a thorny bush indigenous to the Taiga region of the Far East, which includes southeastern Russia, northern China, Japan and Korea. The key active ingredient of Eleuthero is Eleutherosides A-G. This group is chemically heterogenous. Eleutheroside A is the ubiquitous phytosterol daucosterol. Eleutheroside B (syringin) is a phenyl propanoid, whereas Eleutheroside B1 is a coumarine derivative. Eleutheroside C is ethyl-α-D-galactoside. Eleutheroside D and its diastereoisomer Eleutheroside E are lignin derivatives. Eleuthero is the only reported plant source for Eleutherosides. The structures are as follows:

Eleutherosides fractionation from fenugreek is not reported in the prior art.
One of the nine stereoisomers of Inositol is Myo-inositol. This myo-inositol act as a precursor for the synthesis of pinitol that is most abundant in soybeans.
Pinitol is a methylated cyclic sugar alcohol (cyclitol). Pinitol is a cyclitol corresponding to the methylated form of D-chiro-inositol and more concretely it is 3-O-methyl-1,2,4 cis-3,5,6 transhexahydroxycyclohexanol. It has been found in bacteria, fungi, algae and plants. It also occurs widely in plants such as: soya, in leaves of Bougainvillea spectabilis, etc.
Pinitol can also be obtained by chemical synthesis, but until now the process has been very expensive. It is a normal component of the human diet. It is present in soya at about 1% of dry weight. It plays an important role in osmoregulation and osmoprotection. Pinitol fractionation from fenugreek is not reported in the prior art.
There are no teachings in the prior art which disclose that Eleutherosides and pinitol are present in and obtained from fenugreek.
The present disclosure provides a composition and a process of obtaining the composition which aims at addressing the challenges existing in the field of treating neuropathy related disorders.